September 1, 2022 – The Centers for Disease Control (CDC) today approved the use of vaccines designed to target both Omicron and older variants of the coronavirus, a move that may help achieve the goal of a large-scale vaccination campaign before winter sets in in the United States.
The Centers for Disease Control (CDC) Immunization Practices Advisory Committee on Thursday voted 1-1 on two separate questions. One sought the committee’s support to use a single dose of a new version of the Pfizer COVID-19 vaccines for people 12 and older. The second question addressed a single dose of Moderna’s reformulated vaccine for people 18 years of age and older.
The federal government wants to speed up use of the renewed COVID-19 shots, which the FDA on Thursday approved for use in the United States later, CDC director Rochelle Wallinsky agreed with the committee’s recommendation.
“The updated COVID-19 boosters are designed to provide better protection against the latest circulating COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has diminished since the previous vaccination, and are designed to provide broader protection against the latest variants. This recommendation came after Thorough scientific evaluation and robust scientific discussion. If you qualify, there is no bad time to get a COVID-19 booster and I highly encourage you to get one.”
Wednesday’s FDA vote expanded the EUA’s emergency use authorization for both Moderna and Pfizer’s original COVID-19 vaccines. New products are also called “refreshed boosters”. Both contain two components of SARS-CoV-2 RNA, one from the original strain and one found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
Essentially, the FDA paved the way for these new boosters after relying heavily on results from some blood tests that suggested an increased immune response from the new formulations, as well as 18 months of safe use of the original versions of the shots.
However, what neither the FDA nor the CDC have, is evidence from studies in humans about how well these new vaccines work or whether they are as safe as the original versions. But the FDA looked at the clinical evidence for the old shots and the results of studies of the new reinforcers in mice.
ACIP panelist Pablo Sanchez, MD, of Ohio State University was the only one to vote “no” on every question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitation already. We need the human data,” Sanchez said.
Sanchez had no doubts that newer versions of the vaccine would prove safe.
“Personally, I’m in the age group where I’m at high risk, and I’m sure I will,” Sanchez said. “I just feel like this was a bit premature, and I wish we’d seen that data. Having said that, I’m relieved that the vaccine will probably be as safe as the others.”
Sanchez wasn’t alone in raising concerns about support for new COVID-19 shots for which there is no direct clinical evidence from human studies.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion that she would vote “reluctantly” in favor of updated vaccines. She said she believes they will have the potential to reduce hospital admissions and even deaths, even as questions remain about the data.
Long joined other committee members in referring to tHe’s getting close to updating flu vaccines as a model. In an effort to keep up with the flu, companies are seeking to defeat new strains by making modifications to their FDA-approved vaccines. Long said there isn’t a lot of clinical information available about these modified products. I compared it to remodeling an existing home.
“It’s the same scaffolding, part of the same roof, we just put in some windows and dormer windows” with the revisions to the flu vaccine, she said.
Earlier today, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, New York, used changes to annual flu vaccines as a model for developing COVID-19 shots.
“So after thinking about it, I feel comfortable despite the lack of human data,” he said.
There were many questions during the meeting about why the FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee regarding these bivalent vaccines. In this case, however, the agency acted on its own.
The FDA said that the committee had considered new bivalent COVID-19 boosters in previous meetings and that there had been adequate external feedback.
Dorit Reese, PhD, from the University of California Hastings School of Law, said during a public comment session for the CDC advisory meeting that a meeting of advisors on these specific products could have helped build public confidence in these drugs.
“We hope that the vaccines will be more effective against infection, but they are safe and prevent hospitalization and death,” she said.
Expect ACIP support
The Department of Health and Human Services expected ACIP’s support and expects Walensky’s endorsement to follow. On Wednesday, the Department of Strategic Preparedness and Response began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Ross, PhD, chief operating officer for coordination and response operations at HHS, wrote in a blog post.
“Pending a recommendation from the Centers for Disease Control and Prevention, people will soon be able to get — for free — the updated COVID-19 booster shot that contains the Omicron ingredient,” Rouss Books. “These boosters will be available at tens of thousands of vaccination sites they’ve used previously, including local pharmacies, doctors’ offices, and vaccine centers operated by state and local health officials.”
Hearing, Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, September 1, 2022.
Food and Drug Administration: “The FDA’s Critical Role in Ensuring Influenza Vaccine Provision.”
Managing Strategic Preparedness and Response: “ASPR begins distributing updated COVID-19 boosters.”